Health claim: Xanthohumol in XERME® and protection of DNA from oxidative damage

Following an application from TA-XAN AG, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence.

The general approach of the NDA Panel for the evaluation of health claims applications is outlined in the EFSA general guidance for stakeholders on health claim applications and the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health.

The food proposed by the applicant as the subject of the health claim is ‘xanthohumol presented as xanthohumol-enriched roasted malt extract (XERME®)’. The Panel considers that xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, which is the subject of the health claim, is sufficiently characterised.

The claimed effect proposed by the applicant is ‘helps to maintain the integrity of DNA and protects against oxidative damage in the cells of the body’. The proposed target population is ‘adults in the general population’. The Panel considers that protection of DNA from oxidative damage is a beneficial physiological effect.

The only human study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of xanthohumol in XERME® on the protection of DNA from oxidative damage.

In the absence of evidence for an effect of xanthohumol in XERME® on the protection of DNA from oxidative damage, the studies provided by the applicant on the proposed mechanisms by which the food/constituent could exert the claimed effect were not considered by the Panel for the scientific substantiation of the claim.

On the basis of the data provided, the Panel concludes that a cause and effect relationship has not been established between the consumption of xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage.